BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013413 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04001
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: UNKNOWN. CATHETER MODEL: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6), EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE ER WITH SYMPTOMS OF "MORE SEDATED THAN NORMAL", HEART RATE DECREASED, AND BLOOD PRESSURE DECREASED. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN ALTERED MENTAL STATUS, OVERDOSE SYMPTOMS, AND WAS "HARD TO ROUSE." THE PUMP WAS SET TO A MINIMUM RATE WHICH WAS A 97% DECREASE. BY THE TIME THE PUMP WAS TURNED TO A MINIMUM RATE THE PATIENT WAS "ALERT AND VITAL SIGNS WERE STABLE." THE PUMP WAS INFUSING INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116036 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| O| R